CELZ-201-001 Clinion ePRO

CELZ-201-001 Clinion ePRO collects patient outcomes via an app synced to EDC. Subject will provide the details are given in the instructions. Please enter glucose values at least before meals and at bedtime and up to 7 times per day (before meals, 2hr after meals and at bedtime). Record glucose values in the appropriate spaces indicated by the times listed on the sheet. o Each day starts at midnight (12:00 AM) exactly and ends at 1 minute before midnight (11:59 PM). o IF you experience an episode compatible with hypoglycemia, if another person is required to assist you and you recover after oral or intravenous glucose or glucagon, please record the event on the Blood Sugar Record. Record the number of insulin units you take with each injection or meal bolus. Please note the type of insulin, abbreviate Lantus as L, Levemir as D, Tresiba as T, NPH as N, Regular as R, Humalog as H, Novolog as A, Apidra as G, and FiAsp as F. If you use an insulin pump, in addition to recording the bolus doses, please record the total basal dose at the end of the row in the total insulin column. Record the appropriate meal code in the corresponding time space. It is very important that these meal codes be recorded. Meal Codes 1: Pre- meal blood sugar 2: 2 hour post- meal blood sugar 3: Bedtime